KQB368 as a single-drug treatment for adults with advanced solid tumors
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
Run by Kumquat Biosciences Inc. · NCT07542704 · Data updated 2026-11-12
This study tests whether taking KQB368 by mouth every day can help shrink tumors and is safe for adults with advanced solid cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Status | Recruiting |
| Started | May 27, 2026 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07542704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with unresectable or metastatic solid tumors, specifically those with KRAS G12C or KRAS G12S mutations, who have measurable disease and adequate organ function.
✕Probably not a fit
Patients whose tumors do not respond to KQB368 or who experience intolerable side effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, interventional study to evaluate KQB368 as a monotherapy in adults with advanced solid malignancies, including colorectal cancer, non-small cell lung cancer, uterine cancer, and cancers with KRAS G12C or G12S mutations. The primary goals are to determine a safe starting dose, observe changes in tumor size, and understand how the drug is processed by the body. Participants will take KQB368 orally in 21-day cycles and visit the clinic regularly during the first 5 weeks, then at the start of each subsequent cycle. The study will monitor safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity using RECIST v1.1 criteria.
Why it matters
Potential benefit: Participants may experience tumor shrinkage or disease stabilization if the drug is active, contributing to the understanding of KQB368’s potential.
How similar studies have gone: Phase 1 trials of similar targeted agents have shown safety signals and early activity in solid tumors, but this specific agent is novel and its efficacy is still being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
* Histologically confirmed diagnosis of a solid tumor * Malignancy with either a KRAS G12C or KRAS G12S mutation * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 * Must be able to swallow with no GI condition that prevents absorption
Where it's running
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START Los Angeles
Los Angeles, California, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Karmanos Cancer Institute
Detroit, Michigan, United States Recruiting -
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
UH Cleveland Medical Center
Cleveland, Ohio, United States Recruiting
Show 8 more locations
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Providence Cancer Institute
Portland, Oregon, United States Recruiting -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
NEXT Oncology Austin
Austin, Texas, United States Recruiting -
START Dallas Fort Worth
Dallas, Texas, United States Recruiting -
START San Antonio
San Antonio, Texas, United States Recruiting -
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States Recruiting -
NEXT Oncology Virginia
Fairfax, Virginia, United States Recruiting
Study contacts
- Study coordinator: Kumquat Clinical Development Telephone
- Email: kumquatstudies@kumquatbio.com
- Phone: 858.214.2700
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
First-in-human test of CKD-703 for advanced solid tumors and non-small cell lung cancer
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BPI-572270 in RAS-mutant advanced solid tumors (including NSCLC, CRC, PDAC)
This study tests whether BPI-572270 is safe and tolerable in adults with RAS-mutant advanced solid tumors and looks for signs of clinical activity.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.